Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03122717
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gefitinib — DRUG
    gefitinib is a EGFR inhibitor
  • Osimertinib — DRUG
    An orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor

Study Details

This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The interventions involved in this study are: * Osimertinib (Tagrisso) * Gefitinib (Iressa)

Key Dates

Start date
May 9, 2017
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gefitinib + Osimertinib
    * Gerfitinib will administered orally at a pre determine dose daily * Osimertinib will administered orally at a pre determine dose daily

Primary Outcome Measure

Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles [ Time Frame: 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-

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